Identity
- Trade Name
- Dilator Impactor, FH7 ENDO EUDAMEDNA FDA UDI
- Generic Name
- Orthopaedic implantation hammering attachment FDA UDI
- Device Name
- FlareHawk Dilator Impactors EUDAMEDDilator Impactor, FH7 ENDO FDA UDI
- Model / Reference
- CMP-01431 EUDAMEDFDA UDI
- Description
- Dilator Impactor, FH7 ENDO FDA UDI
Identifiers
- Catalog Number
- CMP-01431 FDA UDI
- Primary DI / UDI-DI
- 00810004729773 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081000472INSTMANACCESSMV EUDAMED
- Direct Marketing DI
- 00810004729773 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implantation hammering attachment FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dilator Impactor, FH7 ENDO by Integrity Implants Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0081000472INSTMANACCESSMV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Integrity Implants Inc.
- EUDAMED SRN
- US-MF-000009805
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2fb20781-1be5-4c06-a2b6-0354184f7879 61 fields · synced Jun 18, 2026
- FDA UDI aa9785c4-dcf9-4b47-a6e8-6901bee34ef0 35 fields · synced May 25, 2026